Important Safety Information Regarding NIOX VERO® (Germany)

NIOX VERO® is a portable system for the non-invasive quantitative simple and safe measurement of Nitric Oxide (NO) in human breath (FeNO) and Nasal Nitric Oxide (nNO) in the aspirated air from the nasal cavity. For FeNO: Nitric Oxide is frequently increased in some inflammatory processes such as asthma and decreases in response to anti-inflammatory treatment. FeNO measurements should be used as part of a regular assessment and monitoring of patients with these conditions. NIOX VERO FeNO is suitable for patients age 4 and above. As measurement requires patient cooperation, some children below the age of 7 may require additional coaching and encouragement. NIOX VERO FeNO can be operated with 2 different exhalation times, 10 seconds and 6 seconds. The 10 second mode is the preferred mode. For children who are not able to perform the 10 second test, the 6 second is an alternative. The 6 second test should be used in caution with patients over the age of 10. It should not be used in adult patients. Incorrect use of the 6 second exhalation test may result in falsely low FeNO values, which can lead to incorrect clinical decisions. For nNO: nNO has been shown to decrease in patients with Primary Ciliary Dyskinesia (PCD) and measurement of nNO can assist in the identification of cases of PCD. Measurement of nNO is suitable for patients age 5 and above. Suspected cases of PCD following screening with nNO should be confirmed according to published recommendations for PCD diagnosis and management.

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